QMS, IPQA Executive in Cadila Pharmaceuticals Ltd.

Job Posted on Jul 20, 2017

Company Name:Cadila Pharmaceuticals Ltd.
Address:Corporate Campus | Bhat | Ahmedabad - 382210
Ahmedabad, Sarkhej Dholka Road ahmedabad
Contact Person:Celine Vinod
Email Address:celine.vinod@cadilapharma.co.in
Required in:Formulation Unit
Job Department(s):Quality Assurance
Job Title:QMS,IPQA Executive
Qualification:M.Sc. Biotechnogy, M.Sc. Microbioloy
Job Details:Major Purpose:
• To perform the in process quality checks for control on production for the process / product being manufactured in Bio-pharmaceutical field.
• To ensure Quality and cGMP compliance of the products being manufactured.
• Hands on experience in QMS & Compliances

1. To ensure and verification in-process checks for manufacturing of Bio-bulk and Finished Products
2. Area clearance for scheduled manufacturing activities for Drug Substance and Drug Product (Finish Product).
3. Cell Bank management, such as issuance, trending monitoring and reconciliation.
4. Review of the Batch Manufacturing Records, Batch Packing records, in process analytical docket, final release analytical docket and all other supporting cGMP documents related to scheduled batch release activity of Drug Substance and Drug Product.
5. Plant round for in process quality assurance check activity for manufacturing facilities during batch manufacturing activity.
6. Preparation and review of protocols and reports
7. QMS Compliance:
• Change control management
• Deviation management
• Out of specification (OOS)
• Out of Trends (OOT)
• Market complains
8. Preparation/Review of Annual Product Quality Review.
9. Self inspection of the Areas in adherence to schedule.
10. Cross function co-ordination for any QA related activities.
11. Preparation and execution of Risk analysis of the product.
12. Document Review
• SOPs
• Master manufacturing documents
• Batch processing records
• Protocols (Process validation and Aseptic Process Simulation)
13. Preparation/Review of trend analysis.
14. Cross function co-ordination for any QA related activities.
Regulatory Exposure:Not Required
Experience:1-5 yrs
Salary Per Annum:3.5 lacs to 5.5 lacs
Last Date:01/08/2017
Additional Details:Position is based at Dholka - Gujarat.
Note:Please send your resume to above email address to apply for this job.

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